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Compliance and Enforcement of the Privacy Rule

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HHS/OCR February/March 2003. 2. Compliance Date ... HHS/OCR February/March 2003. 10. Civil Monetary Penalties (CMPs) CMPs can be imposed by OCR: ... – PowerPoint PPT presentation

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Title: Compliance and Enforcement of the Privacy Rule


1
Compliance and Enforcement of the Privacy Rule
2
Compliance Date
  • April 14, 2003 Compliance for all but small
    health plans
  • One year extension for small health plans
  • No statutory extension available in Privacy Rule,
    unlike extension available for Transaction Rule
    through 10/16/03

3
Office for Civil Rights
  • Enforces Civil Rights laws and the Privacy Rule
  • With respect to the Privacy Rule
  • Promote voluntary compliance
  • Investigation and Resolution of Complaints
  • Exception Determinations

4
Why Voluntary Compliance?
  • Promoted by HIPAA statute and Privacy Rule
  • Education, Cooperation, Technical Assistance
  • Permitted even after investigation commences
  • Can help mitigate CMPs
  • Most efficient way to promote privacy

5
Technical Assistance
  • Integrated Rule and Preambles to Dec. 2000, Aug.
    2002 Final Rules
  • Covered Entity decision tool
  • December 4, 2002 Guidance
  • Targeted Technical Assistance materials under
    development
  • Fact sheet on August 2002 modifications
  • Sample Business Associate Contract
  • FAQs on our website
  • http//www.hhs.gov/ocr/hipaa/

6
December 4, 2002 Guidance
  • General Overview
  • Incidental Uses and Disclosures
  • Minimum Necessary
  • Personal Representatives
  • Business Associates
  • Uses and Disclosures for Treatment, Payment and
    Health Care Operations
  • Marketing
  • Public Health
  • Research
  • Workers Compensation Laws
  • Notice
  • Government Access
  • Miscellaneous FAQs

7
Investigations Compliance Reviews
  • OCR may investigate complaints
  • OCR may conduct compliance reviews to determine
    whether Covered Entities are in compliance

8
Filing Complaints
  • Any person or organization may file complaint
    with OCR by mail or electronically
  • Only for possible violations occurring after
    compliance date
  • Complaints should be filed within 180 days of
    when the complainant knew or should have known
    that the act or omission occurred
  • Individuals may also file complaints with Covered
    Entity

9
Complaint Process
  • Informal review may resolve issue fully without
    formal investigation
  • Many complaints will be resolved at this stage
  • If not, begin investigation
  • Voluntary resolution yet possible
  • Technical Assistance

10
Civil Monetary Penalties (CMPs)
  • CMPs can be imposed by OCR
  • 100 per violation
  • Capped at 25,000 for each calendar year for each
    identical requirement or prohibition that is
    violated
  • Covered Entity has a right to notice and a
    hearing before a CMP becomes final

11
No CMPs if
  • Person did not know and by exercising
    reasonable diligence would not have known - of
    the violation
  • If failure to comply is due to reasonable cause
    and not willful neglect and entity corrects
    within 30 day cure period
  • Offense is punishable by criminal sanction

12
CMP Flexibility Summary
  • Exceptions
  • Potential extension of the 30 day cure period
  • CMP reduction possible if
  • Amount excessive relative to violation
  • Due to reasonable cause/not willful neglect

13
Criminal Penalties for Wrongful Disclosures
  • For knowingly obtaining or disclosing
    identifiable health information relating to an
    individual in violation of the Rule
  • Up to 50,000 1 year imprisonment
  • Up to 100,000 5 years if done under false
    pretenses
  • Up to 250,000 10 years if intent to sell,
    transfer, or use for commercial advantage,
    personal gain or malicious harm
  • Enforced by DOJ

14
Additional Information
  • www.hhs.gov/ocr/hipaa/
  • OCR Privacy Toll Free Number
  • (866) 627-7748
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